Yeah it's pretty confusing, but it sounds like Pfizer's application was to keep the EUA in place and extend it
Yeah it's pretty confusing, but it sounds like Pfizer's application was to keep the EUA in place and extend it
This looks like a licensing letter:
This looks like a licensing letter:
https://www.fda.gov/media/151710/download
Super weird if BLA approval means they have full FDA approval because the document requires a litany of long term studies to assess adverse effects of the product.
I assumed those studies were done before a product gets 'full approval'
Super weird if BLA approval means they have full FDA approval because the document requires a litany of long term studies to assess adverse effects of the product.
I assumed those studies were done before a product gets 'full approval'
This statement is the one that I'm struggling with:
We are issuing Department of Health and Human Services U.S. License No. 2229 to BioNTech Manufacturing GmbH, Mainz, Germany, under the provisions of section 351(a) of the PHS Act controlling the manufacture and sale of biological products.
This statement is the one that I'm struggling with:
We are issuing Department of Health and Human Services U.S. License No. 2229 to
BioNTech Manufacturing GmbH, Mainz, Germany, under the provisions of section
351(a) of the PHS Act controlling the manufacture and sale of biological products.
(post is archived)